Why Moderna Doesn't Own Its Covid Vaccine - YouTube

Covid vaccines have changed the course of the pandemic. They

prevented over 1 million deaths in the US and over 10.3 million

hospitalizations in 2021. But what's equally impressive was

the speed and efficiency in which they were created.

I've never seen the level of intensive collaboration, like

wanting to try and figure this out, between public private

partnership form in my 20 year career.

However, the groundbreaking collaboration might be giving

away to another looming battle on the horizon. A battle over

who truly owns the Covid vaccine.

We are following a developing story. Moderna, the drugmaker

locked in a fight with the NIH over its Covid vaccine.

These two entities have essentially been partners on the

Covid vaccine. But now they are in a battle over one of the key

patents behind it.

Patents have historically been viewed as important in part

because they assure the company that if they are successful in

getting the drug to market that they stand to have essentially a

monopoly on the rights to sell that drug for a certain period

of time, typically say around 20 years.

Whenever there is a blockbuster drug, there are disputes about

who owns it, who owns variations of it, who owns it for how long

and in what context. We are likely to see these battles

playing out in the US courts and in international courts for a

long time.

Controversy over Covid vaccine patents has grabbed the

attention of the world and the likes of President Biden and

Bill Gates. And its outcome could have ramifications on how

the world ends the pandemic.

Like any other invention, vaccines are often covered by

patents that provide legal protection against imitation.

That's because investing in pharmaceutical research can be

an expensive and risky gamble. On average, developing a new

drug can range from less than $1 billion to more than $2 billion

per drug. Yet, just under 14% of all drugs and clinical trials

eventually win approval from the FDA to make their way to the

market.

There are tons and tons of research and development or

patents or papers or initiatives that get spun up that never

really go anywhere, that don't really see light a day. I did a

general search on Google patents. Anybody can do this.

Looked at vaccines for Covid, right? I found one that's known.

I just literally said, "how many other patents are sort of kinda

like that?" The number that got spit out on Google patents was

134,000 patents that you would never know, never seen them,

never heard about them, that all were somehow related to research

in the area that led ultimately to that patents that's in the

market.

A successful pattern, however, can often result in a big

payoff. Not only does it give the inventor the sole right to

produce and sell their products, but it also allows them to earn

royalties whenever their patent is used to create a product.

Patents have historically been presented as a way to reward a

company that has developed and brought a drug to the market snd

to compensate it for all of the costs that were incurred in

getting it to the market. They stand to have essentially a

monopoly on the rights to sell that drug for a certain period

of time, typically say around 20 years,

Lawsuits over valuable pharmaceutical patents have been

common throughout history.

A fair percentage of the litigation that happens in the

United States relates to pharmaceutical patents. Our

legal system spends a lot of time trying to figure out who

owns what and what are the boundaries of those rights.

Pharmaceutical patents, if they lead particularly to Blockbuster

medicines, have a lot of money at stake. So that means there a

lot of resources to hire lawyers to try to argue over who owns

what.

In November 2021, a similar conflict broke out over the

COVID-19 vaccine, putting Moderna at odds with the US

government. Moderna collaborated with the researchers at the

National Institute of Health, a federal agency to develop their

vaccine, Spikevax. When Maderna excluded the NIH researchers as

Co-inventors in a central patent covering the mRNA sequence, NIH

publicly challenged the patent arguing that three of its

scientists made meaningful contributions to its research.

When you have large industry, you have government and you're

trying to blend commercial interest with governmental

do-good interest, there's always going to be some kind of natural

tension. That's to be expected.

They are arguing over methods of stabilizing the spike protein

within the vaccine. So it's critically important to the

Moderna vaccine, who actually owns that. If the government is

listed on the patent, then it has remarkable control over what

the parties can do with it.

While Maderna eventually backed down in their fight against the

NIH, the dispute could foreshadow more to come. Another

dispute can potentially rise over NIH's patent for the spike

protein that allows the vaccine to induce a stronger immune

response. While companies like Pfizer paid money to obtain a

license from NIH, Moderna did not. But it could also be facing

another patent infringement lawsuit by Arbutus biopharma

Corp, a company with a similar patent on its delivery system.

Multiple reports surrounding Maderna's patent complications

haven't helped with the company's dwindling performance

in the market. In October 2020, Pfizer was also sued by a low

biotechnology and pharmaceuticals for allegedly

using their proteins in their vaccine testing that infringe on

their existing patent.

I do anticipate going forward that we're gonna see more

lawsuits and disputes arise over COVID-19 vaccine patents. I

think at some level, it's pretty much unavoidable.

We are likely to see these battles playing out in the US

courts and in international courts for a long time to come.

The Covid vaccine patents can also pose other threats beyond

legal conflict. Patents within the US also extend throughout

the world thanks to an international agreement known as

TRIPS. Some experts argue this is why vaccines are less

accessible in the lower income countries.

The existence of patents and specifically, intellectual

property protections does two things. One is it limits how

much manufacturing there can be of that product or that vaccine.

And the other thing that it does is it keeps the price of that

product and vaccine artificially high or keeps it high enough

that it limits the ability of other countries in the world,

particularly low, middle-income countries to be able to purchase

those vaccines.

In response, calls to waive the patents on Covid vaccines have

continuously gained traction throughout the world.

Some of the recent ideas that have been floated include things

known as patent waivers, which is basically saying okay, you

may have a patent but we're going to administrate and say

that patent no longer gives you protection to market. You have

to give your recipe away to everybody in an effort to get

more vaccines out there to help get us as a global economy back

on their footing.

In October 2020, India and South Africa first brought the matter

to the spotlight after formally proposing the WTO to waive

intellectual property rules over the Covid vaccines. While

patents might have a place in the normal world, the hope is

that the pandemic could force countries to consider an

exception.

Until we have full vaccination around the world, we're going to

continue to see new variants arise. And every time there's a

new variant, we're going to realize very quickly that it's

not possible to contain that variant in just one part of the

world.

The world can't wait. Certainly can't wait 20 years the patent

to end, but it can't even wait for the period of time necessary

to get through the existing waiver processes.

There is also the question of ethics. The US government played

a major role in funding the vaccine. Research from 2021

discovered that most of the technology used for the Covid

vaccine was mostly funded by the public sector. So is it ethical

for drug companies to make a profit off of their patents?

The reason that public investment happens is that we're

trying to protect the public from new diseases, protect and

improve the health of the public. And so I do think there

are some major concerns with specific companies making large

amounts of profits from drugs that were developed, in part

with the federal government's support. And moreover, when the

health of the public is also suffering at the same time.

But not everyone is in support of a patent waiver. Critics

argue that such an unprecedented move will only have dire

consequences in the long run.

If we create that slippery slope, patents are devalued

because legally they're not protected in the more global

level. We're going to be disincentivizing innovation at a

massive, massive level.

There is also conflicting opinion on whether a waiver can

actually improve global vaccine distribution. Bill Gates also

originally spoke out against the patent waiver, arguing that

there are problems beyond patents that stay in the way of

global vaccination, although he later reversed his position.

If you don't have the actual healthcare infrastructure that

can deliver those. You don't have the logistics and

transportation components that are there. Having a billion

vaccines sitting in a warehouse of a lab that's developing it

will do no good for getting us back to normal.

While the debate remains a hot topic among scholars throughout

the world, many expressed doubts on whether a patent waiver can

actually come to fruition.

The likelihood that at a global level, because it is not a US

decision, it's a global World Intellectual Property

Organization decision to be clear, that we will get to a

point where we're going to say, "Yeah, we're going to use a

TRIPS waiver in this case," I doubt it very seriously.

I think we had the best hope of it was last year when there was

a proposal that was put forward at the WTO and the Biden

administration had supported it. But we had European countries

that objected to those patent waivers.

No matter the outcome, the current debate over intellectual

property will have a lasting impact on global public health.

This is not the last pandemic and it's not the last epidemic.

We are going to face these questions of how we encourage

innovation, how we make sure it spreads through the world in an

accessible manner. These are issues that will plague us long

after Covid-19 hopefully, God willing has been solved and

we've learned to live with it.